Dynamic Skin Recovery SPF30

Dosage form: lotion
Ingredients: AVOBENZONE 30uL in 1mL, OCTINOXATE 75uL in 1mL, OXYBENZONE 5uL in 1mL, OCTISALATE 5uL in 1mL
Labeler: PureTek Corporation
NDC Code: 59088-856

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

active ingredients:Avobenzone (3.0%), Octinoxate (7.5%), Octisalate (5.0%), Oxybenzone (5.0%).

other ingredients:Water (Aqua), Octyldodecyl Neopentanoate, Butylene Glycol, Pentylene Glycol, Arachidyl Alcohol, Behenyl Alcohol, Nylon-12, Leuconostoc/Radish Root Ferment Filtrate, Arginine/Lysine Polypeptide, Pamlitoyl Tripeptide-5, Camellia Sinensis Leaf Extract, Arachidyl Glycoside, Glycine Soja (Soybean) Protein, Sodium Hyaluronate, Saccharomyces Lysate Extract, Oenothera Biennis (Evening Primrose) Oil, Glucosamine HCl, Allantoin, Squalane, Algae Extract, Yeast Extract, Chrysanthemim Parthenium (Feverfew) Extract, Colloidal Oatmeal, Urea, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Cocamidopropyl PG-Dimonium Chloride Phosphate, Glycerin, Disodium EDTA, Citronellol, Eugenol, Geraniol, Limonene, Linalool, Helianthus Annuus (Sunflower) Seed Oil, Rose Flower Oil, Citrus Medica Limonum (Lemon) Peel Oil, Pelargonium Graveolens Oil, Citrus Medica Limonum (Lemon) Peel Extract, Eugenia Caryophyllus (Clove) Flower Oil, Pelargonium Groveolens Flower Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Caprylic/Capric Triglyceride,Titanium Dioxide (Cl 77891). 

directions:

Apply to face and neck, preferably 30 minutes prior to daylight exposure.

warnings:

For external use only, not to be swallowed. Avoid contact with eyes. If contact occurs, flush thoroughly with water. Apply prior to sun exposure. Discontinue use if skin irritation develops or increases. If irritation persists, consult a health care practitioner. Do not use on infants under 6 months old. Contains Oxybenzone.

Label

DYNAMIC SKIN RECOVERY SPF30 
avobenzone, octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-856
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE30 uL  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE75 uL  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE5 uL  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE5 uL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
OCTYLDODECYL NEOPENTANOATE 
BUTYLENE GLYCOL 
PENTYLENE GLYCOL 
ARACHIDYL ALCOHOL 
DOCOSANOL 
ALLANTOIN 
HYALURONATE SODIUM 
SACCHAROMYCES LYSATE 
EVENING PRIMROSE OIL 
GLUCOSAMINE HYDROCHLORIDE 
SQUALANE 
YEAST 
UREA 
PALMITOYL TRIPEPTIDE-5 
GREEN TEA LEAF 
OATMEAL 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYSORBATE 60 
GLYCERIN 
EDETATE DISODIUM 
.BETA.-CITRONELLOL, (R)- 
EUGENOL 
GERANIOL 
LIMONENE, (+/-)- 
LINALOOL, (+/-)- 
SUNFLOWER OIL 
ROSA DAMASCENA FLOWER OIL 
LEMON OIL 
ARACHIDYL GLUCOSIDE 
LEMON PEEL 
CLOVE OIL 
PELARGONIUM GRAVEOLENS FLOWER OIL 
ROSEWOOD OIL 
TITANIUM DIOXIDE 
FEVERFEW 
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE 
ROSE OIL 
GERANIUM OIL, ALGERIAN TYPE 
LEMON 
Packaging
#Item CodePackage Description
1NDC:59088-856-0450 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2009
Labeler - PureTek Corporation (785961046)
Establishment
NameAddressID/FEIOperations
PureTek Corporation785961046manufacture, label, pack, outsourcing human drug compounding, relabel, repack

Revised: 07/2011
 
PureTek Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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